Saddle Block With IT Morphine for Penile Inversion Vaginoplasty

NCT06556121 | Recruiting

• 1 other identifier: 2024-0061-B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Penile Inversion Vaginoplasty (PIV) is a transition-related surgery (TRS) that is associated with severe postoperative pain. The optimal pain management strategies for this surgery remain unknown. We hypothesized that the addition of a saddle block with intrathecal morphine would yield clinically important analgesic benefits.

Conditions

Pain, Postoperative

Keywords

Saddle block; transition; pudendal nerve block; gender confirmation surgery; penile inversion Vaginoplasty

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid (analgesic) consumption

  Consumption intra-operatively, total in-hospital postoperative consumption measured oral morphine equivalents (MEQ)

  48 hours

Secondary Outcomes (6)

• Time to first analgesic request

  24 hours

• Pain Assessment (VAS)

  Up to 48 hours post-operatively

• Incidence of opioid-related side effects

  Up to 48 hours post-operatively

• Presence of Block-related complications

  Up to 48 hours post-operatively

• Quality of Life scores

  48 hours post-operatively

Study Arms (2)

Saddle block with intrathecal morphine Group

EXPERIMENTAL

Patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with 50mL of Normal Saline, 30mL of 0.25% Bupivacaine with epinephrine 1:200.000 and 20mL Lidocaine 1%. A volume of 20 mL of this mixture is used for the pudendal nerve block, and infiltration of the surgical incision and bilateral spermatic cord block is performed with an additional 20 mL of the same mixture of local anesthetic. 30ml of the solution is used to soak the vaginal plug made of gauze that is put inside the vaginal canal by the end of the procedure. Patients who are randomized to the saddle block with intrathecal morphine will receive an injection of 5mg of heavy Bupivacaine 0.75% plus 100mcg of morphine injected in the intrathecal space.

Procedure: Saddle block; Procedure: pudendal nerve block

Control Group

SHAM COMPARATOR

As part of the analgesic plan, all patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with 50mL of Normal Saline, 30mL of 0.25% Bupivacaine with epinephrine 1:200.000 and 20mL Lidocaine 1%. A volume of 20 mL of this mixture is used for the pudendal nerve block, and infiltration of the surgical incision and bilateral spermatic cord block is performed with an additional 20 mL of the same mixture of local anesthetic. 30ml of the solution is used to soak the vaginal plug made of gauze that is put inside the vaginal canal by the end of the procedure. Patients in this group will receive a non-invasive sham saddle block in addition to the care standard.

Procedure: pudendal nerve block

Interventions

Saddle block PROCEDURE

The injected solution will be comprised of 5mg of heavy Bupivacaine 0.75% plus 100mcg of Morphine will be injected into the intrathecal space.

Saddle block with intrathecal morphine Group

pudendal nerve block PROCEDURE

As part of the analgesic plan, all patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with a mixture of Local Anesthetic as follows: 50mL of Normal Saline, 30mL of 0.25% Bupivacaine with epinephrine 1:200.000 and 20mL Lidocaine 1%. A volume of 20 mL of this mixture is used for the pudendal nerve block, and infiltration of the surgical incision and bilateral spermatic cord block is performed with an additional 20 mL of the same mixture of local anesthetic. 30ml of the solution is used to soak the vaginal plug made of gauze that is put inside the vaginal canal by the end of the procedure.

Control Group; Saddle block with intrathecal morphine Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: male-to-female transitioning patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III patients
• Ages 18-70 years
• Penile Inversion Vaginoplasty

You may not qualify if:

• Local infection
• History of use of over 30mg oxycodone or equivalent per day.
• Contraindication to a component of multi-modal analgesia
• Complications or adverse events unrelated to the local anesthetic that precludes evaluation of the primary and secondary outcome measures.
• Unable to speak or read English.
• Revision and Vulvaplasty surgeries

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

RECRUITING

Related Publications (6)

• Swisher MW, Dolendo IM, Sztain JF, Alexander BS, Tsuda PS, Anger JT, Said ET. Intrathecal Morphine Injection for Postoperative Analgesia Following Gender-Affirming Pelvic Surgery: A Retrospective Case-Control Study. Cureus. 2023 Mar 27;15(3):e36748. doi: 10.7759/cureus.36748. eCollection 2023 Mar.

  PMID: 37123779 BACKGROUND

• Yung EM, Abdallah FW, Todaro C, Spence E, Grant A, Brull R. Optimal local anesthetic regimen for saddle block in ambulatory anorectal surgery: an evidence-based systematic review. Reg Anesth Pain Med. 2020 Sep;45(9):733-739. doi: 10.1136/rapm-2020-101603. Epub 2020 Jul 22.

  PMID: 32699103 BACKGROUND

• Hein A, Rosblad P, Gillis-Haegerstrand C, Schedvins K, Jakobsson J, Dahlgren G. Low dose intrathecal morphine effects on post-hysterectomy pain: a randomized placebo-controlled study. Acta Anaesthesiol Scand. 2012 Jan;56(1):102-9. doi: 10.1111/j.1399-6576.2011.02574.x.

  PMID: 22150410 BACKGROUND

• DI Filippo A, Capezzuoli T, Fambrini M, Cariti G, Orlandi G, Vannucci G, Borracci T, DI Nallo L, Mazzella M, Petraglia F. Enhanced recovery after gynecological surgery: comparison between intrathecal and intravenous morphine multimodal analgesia. Minerva Obstet Gynecol. 2023 Apr;75(2):145-149. doi: 10.23736/S2724-606X.21.04961-7. Epub 2021 Dec 1.

  PMID: 34851074 BACKGROUND

• Shim JW, Cho YJ, Moon HW, Park J, Lee HM, Kim YS, Moon YE, Hong SH, Chae MS. Analgesic efficacy of intrathecal morphine and bupivacaine during the early postoperative period in patients who underwent robotic-assisted laparoscopic prostatectomy: a prospective randomized controlled study. BMC Urol. 2021 Feb 26;21(1):30. doi: 10.1186/s12894-021-00798-4.

  PMID: 33637066 BACKGROUND

• Chin P, Yuan N, Zaliznyak M, Stelmar J, Garcia M. Effectiveness of Pudendal Nerve Blocks on Postoperative Pain Control and Reduction in Opioid Usage after Gender-affirming Vaginoplasty. The Journal of Sexual Medicine. 2022;19(4, Supplement 1):S79. doi:10.1016/j.jsxm.2022.01.166

  BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Richard Brull, MD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

• Laura Giron-Arango, MD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didem Bozak

CONTACT

416-323-6008; didem.bozak@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patient, anesthesiologist in the operating room
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel-group, double-blind

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: August 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)